AB0924 SMART PILL TECHNOLOGY PROVIDES SAFE AND EFFECTIVE ASSESSMENT OF GASTROINTESTINAL FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS
Authors: I. Barua, H. Fretheim, H. Didriksen, M. N. Carstens, M. Pesonen, V. Sarna, Ø. Midtvedt, Ø. Molberg, A. M. Hoffmann-Vold
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Gastrointestinal dysmotility is a common complication in systemic sclerosis (Sc) patients including slow colonic transit leading to gastrointestinal tract (GIT) symptoms. Fecal microbiota transplantation (FMT) with ACHIM did not improve lower or total GIT symptoms in SSc patients compared to placebo enrolled in the Norwegian multicenter, double-blind, randomized, placebo-controlled ReSScue trial. It is unclear if transit times were impacted by FMT. The SmartPill wireless motility capsule (SmartPill®), measures transit times and peristalsis in patients and was given to a subgroup of patients in the ReSScue trial. <h3>Objectives</h3> To estimate gut transit time and safety of SmartPill® in patients with SSc and predominant lower GIT symptoms. <h3>Methods</h3> Ten patients from the ReSScue trial were included in this SmartPill substudy. The patients followed the required diets and procedures prior swallowing a pH calibrated SmartPill capsule. Two infusions of ACHIM or placebo at week 0 and 2 were given to all participants. SmartPill was given by all participants at week 0 and 11. The primary outcome of this study was the change of transit times in patients with ACHIM and placebo from week 0 to week 11 and safety. <h3>Results</h3> Ten patients were enrolled to receive a SmartPill®, six patients in the placebo group and four patients in the ACHIM group. Baseline characteristics in the placebo and ACHIM groups were comparable, with 2 (20%) males and 8 (80%) females, 90% with limited systemic sclerosis and a median age of 51 and 53, respectively. At week 0 the placebo group had a whole gut transit time (WGT) 35.8 hours ± 13.2 (mean ± SD) compared to 40 hours± 8.1 in the ACHIM group. At week 12 the WGT for the placebo group was 38.1 hours±7.2 compared to 73.5 hours±49.8 in the ACHIM group. There was no significant difference in the change of estimated gut transit time between placebo and ACHIM group regarding whole gut transit time, p=0.158 for week 0 and p=0.752 for week 12. (Figure 1). One patient experienced a delayed transit time after receiving ACHIM, with 254 hours from ingestion to body exit for the SmartPill®. In four cases, the activation of the capsule failed. These patients were included in the trial with new, functional capsules. The reason for the malfunction remained unclear. <h3>Conclusion</h3> FMT with ACHIM did not improve gastrointestinal transit times in patients with SSc and lower GIT symptoms. Our study demonstrates that the SmartPill® is safe to use for patients with SSc, but we experienced a high number of malfunction. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Imon Barua: None declared, Håvard Fretheim Speakers bureau: Boehringer Ingelheim, Consultant of: Bayer, Grant/research support from: GSK/Actelion, Henriette Didriksen: None declared, Maylen N Carstens: None declared, Maiju Pesonen: None declared, Vikas Sarna: None declared, Øyvind Midtvedt Speakers bureau: Boheringer, Øyvind Molberg: None declared, Anna-Maria Hoffmann-Vold Speakers bureau: Boehringer Ingelheim, Jannsen, Medscape, Merck Sharp &amp; Dohme and Roche, Consultant of: ARXX, Boehringer Ingelheim, Genentech, Jannsen, Medscape, Merck Sharp &amp; Dohme and Roche, Grant/research support from: Boehringer Ingelheim, Jannsen.